USPTO Patents Application 09495186

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t. ' -PATENT

.13024/35946

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE *

Applicants:

McMICHAEL et al. -
Serial No.: 09/495,186
Filed: February 1, 2000
For

TREATMENT OF SYMPTOMS
OF ASTHMA, ALLERGIES AND
OTITIS MEDIA

Group Art Unit: 1633
Examiner: Michael C. Wilson

I hereby certify that tljis popep^bping
deposited with the Unite^>^^^^^stal
Service with sufficient pq^t^^^^fst class . • ■ ■
mail in an envelope addreg^ed^tq^ ,
Commissioner for Patents, |£CC Box-1450,
Alexandria, Virginia 22313-1450 on this

July 7, 2003

Jefffey>S. Sharp
Registration No. 31,879
Attorney for Applicants

APPLICANTS* RESPONSE UNDER 37 C.F.R. §1,111

Commissioner for Patents
P.O.Box 1450

Alexandria, Virginia 22313-1450
Sir:

This is in response to the Office Action dated July 3, 2001 in which the Notice of
Allowance issued previously on December 1, 2001 has been withdrawn after payment of the
issue fee on February 27, 2002. Specifically, all pending claims (15-19) stand rejected under
35 U.S.C. §112 (first and second paragraphs). Reconsideration and allowance of the claims
is solicited in light of the following remarks. This response is timely filed as a petition for a
three-months extension of time to July 15, 2003 is submitted herewith.

I. The Outstanding Rejections

Claims 15-19 stand rejected under 35 U.S.C. §112 (first paragraph) for lack of
enablement.

Claims 15-20 (sic 19) stand rejected under 35 U.S.C. §112 (second paragraph) as
being indefinite.

II. Patentability Arguments

A. The Lack of Enablement Rejections of Claims 15-19

Under 35 U.S.C. §112 (First Paragraph) Should Be Withdrawn.

The rejections of claims 15-19 under 35 U.S.C. §112 (first paragraph) for lack of
enablement should be withdrawn because Applicant's invention is not an antibacterial method
but is instead directed to treatment of the symptoms of otitis media.

Contrary to the assumption inherent in the rejection, the reduction of bacteria counts
does not necessarily correlate with otitis media symptoms. While otitis media is frequently
secondary to infection, the elimination or treatment of infection is not necessarily sufficient
or effective to treat the symptoms of otitis media. In fact, the symptoms of otitis media are
thought to be the consequence of an inflammatory response to infection which inflammatory
response is not relieved when the infection is eliminated. (See Exhibit A attached hereto in
which "otitis media" is defined as "acute or chronic inflammation of the middle ear.")

For this reason, whether the administration of DNA to a subject reduces bacteria
count is irrelevant to the issue of whether the therapy effectively treats pain or other
symptoms of otitis media. Thus, the Examiner has failed to present any evidence or logic that
casts doubt on the efficacy of the treatment claimed by Applicant and described in Examples
XX through XXIX of the specification. Accordingly, the rejections of claims 1-7 under 35
U.S.C. §112 (first paragraph) should be withdrawn.

B. The Rejections of Claims 15-19

Under 35 U.S.C, §112 (Second Paragraph) Should Be Withdrawn.

The rejection of claims 15-19 under 35 U.S.C. §112 (second paragraph) as being
indefinite should be withdrawn as the language "so as to not effect gene transfer" is clear and
understandable to those of skill in the art in light of the teachings of the specification. The
invention relates to the administration of DNA for the treatment of symptoms of otitis media
but does not perform this method by transfection or otherwise by the practice of gene
expression or gene therapy. In this context it is clear that "gene transfer" does not relate to
transferring DNA from the bottle to the patient.

It was in the course of prosecution of a related case in which clarification was sought
by the Patent Office Examiner of whether the mechanism of action through which DNA
administration performed its function was by gene therapy effected by gene transfer. In

response to that inquiry the claim language in that application was amended to recite that the
DNA was administered in a manner "so as to not effect gene transfer" in great-grandparent
application U.S. Serial No. 08/755,092 which issued as U.S. Patent No. 5,726,160.
Moreover, each of, 6,096,721, 5,955,442, 5,726,160, and parent patent 6,100,244 comprise
this identical language in their claims. For. the foregoing reasons, the rejection under 35
U.S.C. §112 (second paragraph) should be withdrawn.

For all of the foregoing reasons, the rejections should now be withdrawn and
allowance of all pending claims 15-19 is respectfully solicited. Should the Examiner wish to
discuss any issues of form or substance in order to expedite allowance of the pending
application, he is invited to contact the undersigned attorney at the number indicated below.

CONCLUSION

Respectfully submitted,

MARSHALL, GERSTEIN & BORUN

6300 Sears Tower

233 South Wacker Drive

Chicago, Illinois 60606-6402
(312)474-6300

By:

Registration No. 3 1 ,879

July 7, 2003